MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97800

Device Problems High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  Injury  

Event Description

Information was received from an multiple sources regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that high impedances were observed on the day of surgery.The impedance values >4000 on e0 and e1 repeatedly were observed.The hcp removed the lead from ins, wiped it clean, still had high impedance so this was performed again and no change so ins was replaced.The cause was unknown.Device was replaced with a different ins.The rep added that during a lead change the new lead was inserted into the previous implanted ins and the impedances were 3 times as bad, so ins was replaced.The issue was resolved.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 978b128 lot# va2tvxn, implanted: (b)(6) 2023 explanted: (b)(6) 2024 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: va2tvxn, ubd: 25-apr-2025, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

H3: analysis of the ins 97800, interstim x ssmri, (s/n#: (b)(6)) revealed, suspected bodily fluid on grommet and underneath retaining washer.As received, the set screw was backed out slightly too far, causing damage to the urethane.The screw was still engaged with the threads and could be fastened with a 5 in-oz torque wrench.A star load box and a lab lead were attached to the returned ins; impedances were measured using a lab clinician programmer.The ins passed functional testing.Concomitant medical products: product id: 978b128 lot#: (b)(6), serial#: (b)(6), implanted: (b)(6) 2023, explanted: (b)(6) 2024, product type: lead.H3: analysis of the lead 978b128, istm ii 28cm ssmri, tined (lot # (b)(6)) revealed, upon receipt visual inspection noted, fluid consistent with body fluids in the lead.Each conductor was individually insulated, so there was no impact on the lead or lead performance.Electrical testing determined, that continuity was complete.And there were no electrical shorts between the circuits.Insulation was broken under connections 0, 1 and 2.Insulation was broken under all electrodes.The returned lead was tested with a known good extension.The extension was connected to an ens, while the distal end of the returned lead was places in a 0.9% saline solution.Impedances were measured using the interstim clinician app v2.0.375.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19028371
• MDR Text Key: 339209773
• Report Number: 3004209178-2024-08316
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female